54868-5708 : Clarinex-d (Desloratadine 2.5 mg / Pseudoephedrine Sulfate 120 mg) 12 Hr Extended Release Tablet


NDC54868-5708
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Clarinex-d 12 Hour
Dosage Form: Oral Tablet, Extended Release
Application #: NDA021313
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: D12
Shapes:  Oval
Colors:  Blue / White
Size (mm): 15
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

D12: (0085-1322) Clarinex-d (Desloratadine 2.5 mg / Pseudoephedrine Sulfate 120 mg) 12 Hr Extended Release Tablet by Physicians Total Care, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54868-5708-0: 10 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5708‑0)
  • 54868-5708-1: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5708‑1)

Active Ingredients:

  • Desloratadine
  • Pseudoephedrine Sulfate

Dosage Strength:

  • 2.5 mg
  • 120 mg

Inactive Ingredients:

  • Hypromelloses
  • Cellulose, Microcrystalline
  • Povidone
  • Silicon Dioxide
  • Magnesium Stearate
  • Starch, Corn
  • Edetate Disodium
  • Anhydrous Citric Acid
  • Stearic Acid
  • Fd&c Blue No. 2
  • Aluminum Oxide

Pharmaceutical Classes:

  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]
  • Adrenergic alpha-Agonists [MoA]
  • alpha-Adrenergic Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0085-1322 Clarinex-d (Desloratadine 2.5 mg / Pseudoephedrine Sulfate 120 mg) 12 Hr Extended Release Tablet by Merck Sharp & Dohme Corp.

NDC QR Code

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